A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00354562
First received: July 18, 2006
Last updated: January 5, 2011
Last verified: September 2010
  Purpose

To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.


Condition Intervention Phase
Lung Cancer
Non-Small Cell Lung Cancer
Drug: ABT-751
Drug: Placebo
Drug: Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Subjects may remain on study until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Time-to-Progression (TTP) [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Docetaxel + ABT-751
Drug: ABT-751
200mg ABT-751 daily for 14 days every 21 days
Other Name: ABT-751
Drug: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Docetaxel
  • Taxotere
Placebo Comparator: B
Docetaxel + placebo
Drug: Placebo
Placebo daily for 14 days every 21 days
Other Name: placebo
Drug: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Docetaxel
  • Taxotere

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically documented NSCLC
  • Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
  • Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
  • Only one prior anti-tumor treatment regimen in the curative setting
  • Progressive disease following the previous anti-tumor treatment regimen
  • Measurable disease by RECIST criteria
  • Brain metastasis must be stable and well-controlled

ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent

  • Only one prior anti-tumor treatment regimen in the curative setting
  • Progressive disease following the previous anti-tumor treatment regimen
  • Measurable disease by RECIST criteria
  • Brain metastasis must be stable and well-controlled
  • ECOG performance score 0-2
  • All anti-tumor therapy discontinued at least 3 weeks prior to study entry
  • All adverse events from prior treatment are resolved or stable
  • Adequate hematologic, renal, and hepatic function
  • Females must not be pregnant
  • Willing to take adequate measures to prevent pregnancy
  • Life expectancy of at least 3 months
  • Able to complete the Quality of Life questionnaire
  • Voluntarily signed informed consent

Exclusion Criteria:

  • Greater that Grade 1 neurological findings
  • Allergy to sulfa medications
  • Previous treatment with ABT-751 or docetaxel
  • Receipt of more than one investigational agent for NSCLC
  • Significant weight loss (>10%) within 6 weeks of study entry
  • Glucose-6-phosphate dehydrogenase deficiency or porphyria
  • Significant systemic disease that would adversely affect participation
  • Class 3-4 New York Heart Association classification status
  • Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354562

  Show 32 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Helen Eliopoulos, MD Abbott
  More Information

No publications provided

Responsible Party: Helen Eliopoulos, MD, Global Project Head, Abbott
ClinicalTrials.gov Identifier: NCT00354562     History of Changes
Other Study ID Numbers: M05-782, 2006-002838-38
Study First Received: July 18, 2006
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Lung Cancer
Non-Small Cell Lung Cancer
NSCLC
ABT-751
docetaxel
Taxotere

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014